UK regulator defends rapid approval of vaccine after Fauci criticism

Anthony Fauci, the top US infectious disease specialist, has accused the UK of rushing its world-beating approval of the Pfizer/BioNTech Covid-19 vaccine, suggesting the rapid green light could feed scepticism about its effects.

As the UK’s global first raised hackles among rivals, Dr Fauci told CBS news Britons were “good scientists. But they just took the data from the Pfizer company and instead of scrutinising it really, really carefully, they said, ‘OK, let’s approve it. That’s it.’ And they went with it,” he said. 

Dr Fauci’s broadside follows criticism of the UK’s approval process from the European Union on Wednesday. He insisted the US Food and Drug Administration was the “gold standard of regulation” and that if the FDA had tried to shave a week or a week and a half off the timeline, it would have damaged the credibility of the regulatory process.

The UK’s Medicines and Healthcare products Regulatory Agency responded that it had “rigorously assessed the data in the shortest time possible, without compromising the thoroughness of our review”. Despite the criticism from other countries, the fast approval of the vaccine has fuelled hopes in government and industry that the country can gain a post-Brexit advantage by greenlighting drugs faster than international counterparts.

Ministers, scientists and pharma industry leaders believe the MHRA’s success can help to attract life sciences investment once the UK leaves the EU.

Sir Kent Woods, the MHRA’s founding chief executive, jumped to the support of the agency he led until 2013, saying he was “uneasy about insinuations that this process has been fudged and rushed through”. 

He pointed to the technical assets and knowledge the agency had built around vaccines and clinical assessments, which enabled it to move quickly in its rolling review of Pfizer’s clinical data. “There’s a lot of skill embedded in the organisation that came into play for this process,” he said.

He added: “Anyone who proposes taking longer to get a vaccine out has to explain why it’s going to take longer.”

Norman Baylor, a former director of vaccines research and review at the FDA, said one of the differences in the speed of authorisation between the American and UK regulators stemmed from the fact that the US agency reviewed and analysed every part of the data.

“The scientists and clinical reviewers will actually crunch the numbers and also look at all of the patient information,” he said, while the MHRA tended to accept the data at face value and only questioned the conclusions. 

The MHRA currently falls under the European Medicines Agency. Although the two have decoupled since the EMA moved out of its home in London’s Canary Wharf in 2019, the UK agency formerly undertook about a third of all scientific assessments of new medicines on behalf of the parent body.

Andrew Garrett, executive vice-president at ICON, a clinical research organisation, noted that the EMA “has generally relied pretty heavily on the expertise coming from the MHRA”.

Dr Garrett, who has worked with companies seeking approval for drugs from the EMA, said that when a submission was made “it normally gets shipped out to two different [national] agencies to review it”.

“Personally, I always wanted the UK to be one of the groups because you knew they would do a good job and ask sensible questions.” Some countries “did not always demonstrate this level of expertise consistently”, he added.

Hugo Fry, UK and Ireland head of Sanofi, the Paris-based drug company, said the MHRA was “working very hard to be one of the world’s leading regulators”. Its plans were well advanced to offer companies that wished to bring an innovative medicine or device to market in the UK “a really rapid approval and a bespoke approach”, he added.

This might involve carrying out the same kind of rolling review of data that had allowed such a fast green light for the Covid-19 vaccine.

About two years ago the MHRA approved a Sanofi flu vaccine roughly five months faster than would normally have happened, after agreeing to accept a data file initially prepared for the Australian regulator rather than requiring an entirely new submission. Mr Fry said he believed that had served as “a dry run” for the approach the UK agency now wished to adopt widely.

The need to lure companies to register their medicines in the UK will be particularly pressing post-Brexit. The strength of UK science has always allowed the country’s pharma industry to punch far above its weight, but it commands only about 3 per cent of global sales.

That has raised concerns that UK patients will receive new drugs later than their counterparts elsewhere in the world because a separate application will have to be made to approve the drug for the British market.

Mr Fry warned that the strategy of offering fast-track approvals would only work if the UK also addressed the slow take up of new drugs compared with other countries, and reimbursed them at higher levels.

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